Celsion Corporation (CLSN)

[sdtrond]

Guess I'll reply to all three of these posts in one.

>> (original post) - no real question, just admitting there's a lot of confusion out there.

My synthesis is: They are under an SPA with an interim look. Therefore they definitely have at least one outcome "carved in stone" that would be called "success" and allow an early filing.

Here's the key though... there are numerous other outcomes that they can do different things with. Let's say PFS is marginally short of stat sig (the higher bar at interim) BUT Overall Survival (OS) comes in with some crazy number like 60 in placebo and 8 in treatment arm. [I am NOT saying that is even close to happening!!!] Would you roll the dice and file for early approval?

The thing most don't understand is that the company really can do anything they want. They can file early, or not, regardless of whether success is at interim or not. But the costs and bad PR truly do make it a fairly easy call, most of the time. DNDN filed in 2006 for approval of Provenge even though 1 of the two trials was not stat sig and the second was very small numbers. They almost made it too, the AC voted majority for approval. But the FDA said no, and so they had to wait on IMPACT trial data to get the okay.

Specifically to Mangrove, Celsion is totally passing the buck. Yes, if they changed the trial it would break the SPA, but they can always ask the FDA to amend the SPA (again, refer to Dendreon for an example of successfully changing the SPA in IMPACT and getting a success at the "faster" final because of it). Once amended by the FDA, it is a valid SPA. So yes, they absolutely could go that route, and you should note that asking for that doesn't kill the original SPA.

Finally, it isn't CLSN's call with the data unless it is a success at interim. The DMC could rec a continue and not tell them a durn thing. HOWEVER, they easily could rec a continue but also release anything from a little extra data to full disclosure of hazard ratios, and numbers between arms for PFS and OS.
Once that occurs, as much as shareholders scream, the company does not HAVE to release any of that info (arguably, if bad, they would have to, but why would the continue be recced, in that case?).

>>TGF: re more money

I'm not convinced the raise would be at depressed prices, for very long. By halfway through 2012, I'd expect $6-10, or more. How? Simply virtue of being past an interim, in a major trial (HEAT is the biggest HCC trial ever, from one source), in a major indication with no good alternatives if transplant/surgery is not suggested, that has an SPA and Fast Track and called a Priority Trial by the NIH (one of only 8 such trials) and registrational in 5 different countries. The market should award a market cap of approx. $400-650M to such a company - and even if 4-7M shares are offered before then, that is about 31-33M shares out and we could see the teens in SP.

There'll be a flood of news, even if no early filing, we have accelerated approval and that means they'll start with the rolling NDA after they get some data at interim. China should finish enrolling (HEAT) by the end of Jan. The MLC trial (ph2) starts enrolling in Q4. We'll find out more info on Dignity (ph2) and HIFU (ph2) in the this Q or Q1. "Product #5" details should be released in the next half year as well. Yakult will also use the DMC interim data to design a better Phase 3 for Japan, and they pay all trial costs there.

I think we have enough cash to see us through end of 2Q12, and by that time we should either license or be able to raise more cash ourselves at a pretty good price.

I'm not worried, at all.
Regards,
Trond